MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY SET, SECURE LOCK, 100 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1422128
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Event or Problem Description
The event occurred on an unspecified date in may and involved a primary set, secure lock, 100 inch which was reported to have leaking at the patient bedside during patient infusion.The customer reported that the leak was noticed immediately and observed to be leaking between the spike and the chamber.The affected product was infusing car t cellular therapy abecma - re-engineered cells.There was patient involvement, however, no harm was reported as a consequence of this event.
Additional Manufacturer Narrative
One used device was returned for evaluation.No visual damages or anomalies noted.The set was tested per product specifications.There was no leakage.The reported complaint of leakage was unable to be replicated or confirmed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY SET, SECURE LOCK, 100 INCH
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; MX
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17216928
• Report Number: 9615050-2023-00210
• Device Sequence Number: 3022603
• Product Code: FPA
• UDI-Device Identifier: 10887787006442
• UDI-Public: (01)10887787006442(17)230401(10)4775109
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K142367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: 1422128
• Device Catalogue Number: 142210488
• Device Lot Number: 4775109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAR T ABECMA CELLULAR THERAPY, MFR UNK
• Patient Sex: Unknown